XANOPAN

Main information

  • Trade name:
  • XANOPAN 50/5 latanoprost 50 microgram/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XANOPAN 50/5 latanoprost 50 microgram/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217134
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217134

XANOPAN 50/5 latanoprost 50 microgram/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

16/12/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. XANOPAN 50/5 latanoprost 50 microgram/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle

Product Type

Single Medicine Product

Effective date

16/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to

beta-blockers, prostaglandins or other intraocular pressure lowering medications. It should not be used to initiate therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

24 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Refrigerate

Discard 4 weeks after

opening

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

3 x 2.5 mL

(S4) Prescription Only Medicine

1 x 2.5 mL

(S4) Prescription Only Medicine

Components

1. XANOPAN 50/5 latanoprost 50 microgram/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle

Dosage Form

Eye Drops, solution

Route of Administration

Ophthalmic

Visual Identification

A clear, colorless aqueous solution free from visible extraneous matter.

Active Ingredients

Latanoprost

.05 mg/mL

Timolol maleate

6.83 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:53:33 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Xanopan 50/5 eye

drops

contains the active ingredients latanoprost and timolol (as maleate)

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about Xanopan 50/5.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking Xanopan 50/5

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What Xanopan 50/5 is

used for

This medicine is used to lower raised

pressure in the eye and to treat

glaucoma.

Glaucoma is a condition in which the

pressure of fluid in the eye may be

high. However, some people with

glaucoma may have normal eye

pressure.

Glaucoma is usually caused by a

build up of the fluid which flows

through the eye. This build up occurs

because the fluid drains out of your

eye more slowly than it is being

pumped in. Since new fluid continues

to enter the eye, joining the fluid

already there, the pressure continues

to rise. This raised pressure may

damage the back of the eye resulting

in gradual loss of sight. Damage can

progress so slowly that the person is

not aware of this gradual loss of

sight. Sometimes even normal eye

pressure is associated with damage to

the back of the eye.

There are usually no symptoms of

glaucoma. If glaucoma is not treated

it can lead to serious problems,

including total blindness. In fact,

untreated glaucoma is one of the

most common causes of blindness.

Xanopan 50/5 is made up of 2 active

ingredients, latanoprost and timolol

maleate. Latanoprost works by

allowing more fluid to flow out from

within your eye(s). Timolol maleate

lowers the pressure in the eye by

reducing the production of fluid.

Latanoprost belongs to a family of

medicines called prostaglandin

agonists. Timolol maleate belongs to

a family of medicines called beta-

blockers.

Although Xanopan 50/5 helps control

your glaucoma it does not cure it. So

you must keep using it until your

doctor tells you to stop.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

Xanopan 50/5 is not recommended

for use in children. The safety and

effectiveness of Xanopan 50/5 in

children have not been established.

Before you take

Xanopan 50/5

When you must not take it

Do not take Xanopan 50/5 if you

have an allergy to:

any medicine containing

latanoprost and timolol maleate

any of the ingredients listed at the

end of this leaflet

Some of the symptoms of an allergic

reaction may include

asthma

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

fainting

Do not take Xanopan 50/5 if:

you have asthma, or a history of

asthma, chronic obstructive lung

disease (emphysema) or other

breathing problems

you have certain heart conditions,

such as a very slow heart rate, an

irregular heart beat, or heart

failure

Do not give this medicine to a

child.

Safety and effectiveness in children

have not been established.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

XANOPAN 50/5 EYE DROPS

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

heart disease

lung disease

circulation problems

any other types of glaucoma or

eye conditions

diabetes

myasthenia gravis

hyperthyroidism

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.

Your doctor can discuss with you the

risks and benefits involved.

There is no adequate experience with

Xanopan 50/5 in pregnant women,

therefore it should not be used during

pregnancy.

One of the active ingredients in

Xanopan 50/5 has been detected in

breast milk. Because of the potential

harm to the infant, nursing women

should either stop using Xanopan

50/5 or stop breast-feeding while

using it.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Xanopan 50/5.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines and Xanopan 50/5

may interfere with each other. These

include:

certain medicines used to treat

high blood pressure or heart

conditions such as beta-blockers,

calcium channel blockers or

digoxin

certain medicines used to treat

irregular heart beats such as

amiodarone and quinidine

certain medicines used to treat

depression such as phenelzine,

fluoxetine or paroxetine

some medicines used to treat

Parkinson's disease, such as

selegiline

adrenaline, a hormone used in the

treatment of asthma, slow or

irregular heart beat, acute allergic

disorders and glaucoma

some medicines that may have

been prescribed to help you pass

urine or restore normal bowel

movements

narcotics such as morphine used

to treat moderate to severe pain

eye drops which contain an

ingredient called thiomersal. If

using such eye drops as well as

Xanopan 50/5, you should wait at

least 5 minutes between using

these eye drops and Xanopan

50/5.

medicines used to treat diabetes

or high blood sugar

some other eye drops that contain

a beta-blocker or a prostaglandin.

The use of two or more beta-

blocker eye drops and/or two or

more prostaglandin eye drops at

the same time is not

recommended.

These medicines may be affected by

Xanopan 50/5 or may affect how

well it works. You may need

different amounts of your medicines,

or you may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take Xanopan

50/5

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box/bottle, ask

your doctor or pharmacist for

help.

If you are being changed from one

eye drop to another, follow your

doctor's instructions carefully as to

when to stop the old drops and

when to start the new drops.

How much to take

The usual dose of Xanopan 50/5 is

one drop into the affected eye, or

eyes, once daily.

How to take it

If you are wearing soft contact

lenses, remove them before putting

the drops in your eye.

The preservative in Xanopan 50/5

(benzalkonium chloride) may be

deposited in soft contact lenses. You

can put your soft contact lenses

backing to your eyes 15 minutes after

you have used Xanopan 50/5.

If using other eye drops in addition

to Xanopan 50/5, wait at least 5

minutes before putting any other

drops in your eye(s).

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else.

Touching the dropper tip against

something may contaminate the eye

drops and give you an eye infection.

You may find it easier to put drops in

your eye while you are sitting or

lying down.

1.

Wash your hands well with

soap and water

2.

Twist off the protective overcap

from the bottle

3.

Unscrew the inner cap

XANOPAN 50/5 EYE DROPS

4.

Use your finger to gently pull

down the lower eyelid of your

affected eye

5.

Tilt your head back and look

up

6.

Place the tip of the bottle close

to but not touching your eye.

Squeeze the bottle gently so that

only one drop goes into your

eye, then release the lower

eyelid. Close your eye. Do not

blink or rub your eye

7.

While your eye is closed, place

your index finger against the

inside corner of your eye and

press against your nose for

about two minutes. This will

help to stop the medicine from

draining through the tear duct

to the nose and throat, from

where it can be absorbed into

other parts of your body. Ask

your doctor for more specific

instructions on this technique

8.

Screw the inner cap back on the

bottle

9.

Wash your hands again with

soap and water to remove any

residue

You may feel a slight burning

sensation in the eye shortly after

using the eye drops.

If this persists, or is very

uncomfortable, contact your

doctor or pharmacist.

When to take it

Use Xanopan 50/5 every day, at

about the same time each day, unless

your doctor tells you otherwise.

Using your eye drops at the same

time each day will have the best

effect on your eye pressure. It will

also help you remember when to use

the eye drops.

How long to take it

Continue taking your medicine for

as long as your doctor tells you to.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

If you miss a dose, skip the dose

you missed and take your next dose

when you are meant to.

Do not take a double dose to make

up for the dose you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

If you accidentally put several

drops in your eye(s), immediately

rinse your eye(s) with warm water.

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

swallowed Xanopan 50/5. Do this

even if there are no signs of

discomfort or poisoning.

If Xanopan 50/5 is accidentally

swallowed, or if you use too many

drops, you may feel light-headed or

dizzy, you may faint, have a very

slow pulse rate, or have wheezing or

difficulty breathing. Other effects

include headache, nausea, abdominal

pain, fatigue, hot flushes and

sweating.

You may need urgent medical

attention.

While you are taking

Xanopan 50/5

Things you must do

To make sure Xanopan 50/5 is

working properly, have your eye

pressure checked regularly. Have

your eyes checked regularly for

any other changes, including a

change in eye colour.

A slow change in eye colour, which

may be permanent, has been reported

to occur in some patients who use

Xanopan 50/5. Your doctor will

decide whether you should continue

using Xanopan 50/5.

If you develop an eye infection,

receive an eye injury, or have eye

surgery tell your doctor.

Your doctor may tell you to use a

new container of Xanopan 50/5

because of possible contamination of

the old one, or may advise you to

stop your treatment with Xanopan

50/5.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Xanopan 50/5.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Things you must not do

Do not take Xanopan 50/5 to treat

any other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

If you stop taking it, your eye

pressures may rise again and damage

to your eye may occur.

Things to be careful of

Be careful driving or operating

machinery until you know how

Xanopan 50/5 affects you.

Xanopan 50/5 generally does not

cause any problems with your ability

to drive a car or operate machinery.

However, it may cause blurred vision

XANOPAN 50/5 EYE DROPS

in some people. Make sure you know

how you react to Xanopan 50/5 or

that your vision is clear before

driving a car or operating machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Xanopan

50/5.

This medicine helps most people

with lowering raised pressure in the

eye, but it may have unwanted side

effects in some people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

a slow change in eye colour over

a period of time. The iris may

become more brown in colour

and appear darker. This change

may be permanent and more

noticeable if you are only being

treated in one eye

blurred vision, double vision or

other visual problems

allergic reactions including

redness, swelling and/or itching

of the eye

burning, grittiness or stinging of

the eyes

eye pain

redness or watering of the eye/s

irritation or feeling of having

something in the eye, dry eyes

discharge, itching of the eye/s,

crusty eyelashes

drooping of eyelid/s

darkening, thickening,

lengthening or an increase in the

number of eye lashes and fine

hair on the eyelids

misdirected eye lashes sometimes

causing eye irritation

darkening of the skin of the

eyelids

crusting, redness, thickening,

itching or burning of the eyelids

sensitivity to light

headache

tiredness, weakness

sleepiness

ringing or buzzing in the ears

difficulty sleeping, nightmares

change in mood such as

depression, anxiety or

nervousness

confusion, disorientation or

memory loss

hallucinations

feeling sick (nausea) or vomiting,

upset or painful stomach

diarrhoea

anorexia

dry mouth

change to your sense of taste

cold hands or feet

numbness, tingling and colour

change (white, blue then red) in

fingers when exposed to the cold

(Raynaud's Phenomenon)

numbness or tingling in the

fingers or toes

cough

nasal congestion

hair loss or thinning

less desire for sex

impotence or sexual dysfunction

muscle/joint pain

skin rash

Tell your doctor as soon as possible

if you notice any of the following:

fast or irregular heart beat, also

called palpitations

dizziness and light-headedness,

which may be due to low blood

pressure

skin rash, itching

swelling of hands, feet, ankles or

legs

The above list includes serious side

effects that may require medical

attention. Serious side are rare.

If any of the following happen, stop

taking Xanopan 50/5 and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital:

wheezing, difficulty in

breathing(asthma or worsening of

asthma)

shortness of breath

very slow pulse, chest pain

fainting

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or nettle

rash

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Xanopan

50/5

Storage

Before opening Xanopan 50/5,

keep the bottle in its box in a

refrigerator (2°C-8°C) protected

from light.

After opening Xanopan 50/5, keep

the bottle in its box in a cool place

where the temperature stays below

25°C, but do not refrigerate. Keep

XANOPAN 50/5 EYE DROPS

the box properly closed and

protected from light.

Do not store Xanopan 50/5 or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Put the top back on the bottle right

away after use to avoid

contaminating the eye drops.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Write the date on the bottle when

you open the eye drops and throw

out any remaining solution after

four weeks.

Open a new bottle every 4 weeks.

Eye drops contain a preservative

which helps prevent germs growing

in the solution for the first four

weeks after opening the bottle. After

this time there is a greater risk that

the drops may become contaminated

and cause an eye infection.

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

Xanopan 50/5 eye drops is a clear

and colourless solution come in a

plastic bottle with a dropper and

screw cap inside a protective overcap

containing 2.5 mL eye drop solution,

giving a minimum of 80 drops. This

volume is enough to last 4 weeks if

used in both eyes. Remove this

overcap before use.

Ingredients

Each 1 mL of Xanopan 50/5 contains

50 microgram of latanoprost and 5

mg of timolol (as maleate) as the

active ingredient. Each drop contains

about 1.5 microgram of latanoprost

and 150 microgram of timolol.

It also contains the following inactive

ingredients:

sodium chloride

monobasic sodium phosphate

dibasic anhydrous sodium

phosphate

water for injections

benzalkonium chloride (as

preservative)

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Supplier

Xanopan 50/5 is supplied in

Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

Xanopan 50/5: AUST R 217134

This leaflet was prepared on

16 December 2014

Xanopan 50/5_cmi\DEC14/00

XANOPAN 50/5 EYE DROPS

30-7-2018

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